Description

Cephalexin Hydrate CAS NO 1212823-95-4 is a first-generation cephalosporin antibiotic belonging to the β-lactam class, widely recognized for its broad-spectrum bactericidal activity. It is a critical active pharmaceutical ingredient (API) essential for formulating effective oral antibiotic medications. This compound is primarily required by pharmaceutical manufacturers and research institutions for the production of generic and branded drugs targeting bacterial infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral cephalexin monohydrate capsules, tablets, and suspensions.
• Human Medicine: Formulation of medications for treating respiratory tract, skin, bone, and urinary tract infections caused by susceptible bacteria.
• Veterinary Medicine: Used in veterinary pharmaceuticals for treating bacterial infections in companion animals and livestock.
• Research & Development: Serves as a reference standard and key intermediate in pharmaceutical R&D for new antibiotic formulations and studies.
• Generic Drug Production: A fundamental component for global generic drug manufacturers supplying cost-effective antibiotic therapies.

Basic Information

Item	Detail
Product Name	Cephalexin Hydrate
CAS No.	1212823-95-4
Molecular Formula	C16H17N3O4S • H2O
Molecular Weight	365.41 g/mol
Synonyms	Cephalexin Monohydrate; Cefalexin Monohydrate; (6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate; Keflex; Ceporex; Cepol; Sporidex; Cephalex; Cefalexin Hydrate
EINECS	Contact for details

Quality Control

Our Cephalexin Hydrate is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets high-purity pharmacopeial standards, including USP, EP, and BP monographs. Key parameters such as assay, related substances, water content, and microbial limits are rigorously controlled. A Certificate of Analysis (COA) is provided with each batch to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (on anhydrous basis)	95.0% - 102.0%
pH (1% suspension)	3.5 - 6.0
Water (Karl Fischer)	4.0% - 7.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets EP/USP criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.